Laparoscopic suturing system

ABSTRACT

A laparoscopic suturing device is provided. The suturing device can pass a suturing needle back and forth between jaws of a jaw assembly to suture tissue at a surgical site in a minimally invasive procedure. The jaw assembly can have a pivotable jaw member in each jaw to position the jaw assembly and needle in a low-profile stowed configuration for insertion through a low diameter surgical port. The jaw assembly can be actuated by a handle assembly that provides simultaneous needle passing from a driving jaw to a receiving jaw and latching the needle within the receiving jaw in a single trigger cycle.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. Patent Application Ser. No.15/261,422, entitled, “LAPAROSCOPIC SUTURING SYSTEM,” filed Sep. 9,2016, which claims the benefit of U.S. Provisional Patent ApplicationSer. No. 62/217,502, entitled, “LAPAROSCOPIC SUTURING SYSTEM,” filedSep. 11, 2015. The above-referenced applications are incorporated byreference herein in their entireties.

BACKGROUND OF THE INVENTION Field of the Invention

The present application relates to surgical instruments and moreparticularly to laparoscopic surgical devices for suturing tissue.

Description of the Related Art

In surgical procedures, such as minimally invasive surgical proceduresin which a surgical site is accessed through a port, it can be desirableto suture tissue with a suturing tool that can be advanced through arelatively low-diameter port to the surgical site. A suturing tool canbe configured to advance a needle and attached suture through tissue inthe surgical site such that an operator can create a running stitch toapproximate tissue. Suturing devices have been made that pass a needledown the trocar with the needle's longitudinal axis perpendicular to thetrocar's axis, which limits the length of the needle that may be used inthe device to the inner diameter of the trocar. Moreover, currentsuturing devices typically include operation mechanisms that are complexand cumbersome to operate, requiring multiple operational steps tocomplete a single stitch. Desirably, an improved suturing device caninclude increased efficiency, simplicity and ease of use.

SUMMARY OF THE INVENTION

In certain embodiments, a laparoscopic suturing device is providedherein. The laparoscopic suturing device comprises a handle assembly, anelongate shaft, a jaw assembly, and a needle. The handle assembly has aproximal end and a distal end. The elongate shaft extends distally fromthe distal end of the handle assembly and defines a central longitudinalaxis. The jaw assembly extends distally from the elongate shaft. The jawassembly comprises a first jaw and a second jaw each having a proximalend pivotably coupled to the elongate shaft and a distal end. The jawassembly and the needle are selectively positionable between a stowedconfiguration in which the needle is positioned in one of the first jawand the second jaw and the first jaw, the second jaw, and the needle aregenerally aligned with the central longitudinal axis and an openconfiguration in which the first jaw, the second jaw, and the needleextend transversely to the central longitudinal axis.

In certain embodiments, a laparoscopic suturing device is providedherein. The laparoscopic suturing device comprises a handle assembly, anelongate shaft, a jaw assembly, and a needle. The handle assembly has aproximal end and a distal end. The handle assembly comprises a triggermechanism, a closure mechanism, and a toggle mechanism. The elongateshaft extends distally from the distal end of the handle assembly anddefines a central longitudinal axis. The jaw assembly extends distallyfrom the elongate shaft. The jaw assembly comprises a first jaw and asecond jaw each having a proximal end pivotably coupled to the elongateshaft and a distal end. The trigger mechanism is operably coupled to theclosure mechanism and the toggle mechanism such that an actuation cycleof the trigger mechanism sequentially actuates the closure mechanism toclose the first jaw and the second jaw of the jaw assembly, actuates thetoggle mechanism to transfer the needle from one of the first jaw andthe second jaw to the other of the first jaw and the second jaw, andactuates the closure mechanism to open the first jaw and the second jaw.

In certain embodiments, a laparoscopic suturing system is providedherein. The laparoscopic suturing system comprises a laparoscopicsuturing device and a suturing needle. The laparoscopic suturing devicecomprises a handle assembly, an elongate shaft, and a jaw assembly. Theelongate shaft has a proximal end coupled to the handle assembly and adistal end. The elongate shaft defines a central longitudinal axisextending between the proximal end and the distal end. The jaw assemblyis coupled to the distal end of the elongate shaft. The jaw assemblycomprises a first jaw and a second jaw each pivotably coupled to theelongate shaft and pivotable between an open configuration and a closedconfiguration. The suturing needle is positionable in the jaw assembly.The suturing needle comprises a needle and a suture coupled to theneedle. The needle has a generally curved profile and extends from afirst penetrating tip to a second penetrating tip. The needle comprisesa first shim notch adjacent the first penetrating tip, a second shimnotch adjacent the second penetrating tip, a first recess adjacent thefirst penetrating tip, and a second recess adjacent the secondpenetrating tip.

In certain embodiments, a laparoscopic suturing device is providedherein. The laparoscopic suturing device comprises: a handle assembly,an elongate shaft, and a jaw assembly. The handle assembly has aproximal end and a distal end. The elongate shaft extends distally fromthe distal end of the handle assembly and defines a central longitudinalaxis. The jaw assembly extends distally from the elongate shaft. The jawassembly has a proximal end pivotably coupled to the elongate shaft anda distal end. The jaw assembly comprises a first jaw and a second jaw.The first jaw comprises a first base jaw at the proximal end of the jawassembly; and a first flip jaw at the distal end of the jaw assembly.The first flip jaw is pivotably coupled to the first base jaw. The firstflip jaw has a first needle channel. The first flip jaw is pivotablebetween a stowed position in which the first needle channel is orientedgenerally longitudinally with respect to the first base jaw and asuturing position in which the first needle channel is orientedtransversely to the first base jaw. The second jaw comprises a secondbase jaw at the proximal end of the jaw assembly and a second flip jawat the distal end of the jaw assembly. The second base jaw is pivotablycoupled to the first base jaw and the elongate shaft. The second flipjaw is pivotably coupled to the second base jaw. The second flip jaw hasa second needle channel. The second flip jaw is pivotable between astowed position in which the second needle channel is oriented generallylongitudinally with respect to the second base jaw and a suturingposition in which the second needle channel is oriented transversely tothe second base jaw.

In certain embodiments, a laparoscopic suturing device is providedherein. The laparoscopic suturing device comprises a handle assembly, anelongate shaft, and a jaw assembly. The handle assembly has a proximalend and a distal end. The handle assembly comprises a handle body, atrigger, and a toggle mechanism. The trigger is pivotably coupled to thehandle body. The toggle mechanism is actuatable by pivotal movement ofthe trigger with respect to the handle body. The toggle mechanismcomprises a toggle tube, a first shim, and a second shim. The toggletube is rotatable within the handle body responsive to pivotal movementof the trigger. The toggle tube comprises a shim guide. The first shimhas a proximal end with a first follower positioned in the shim guide.The first shim is longitudinally movable by rotation of the toggle tube.The second shim has a proximal end with a second follower positioned inthe shim guide. The second shim is longitudinally movable by rotation ofthe toggle tube. The elongate shaft extends distally from the distal endof the handle assembly and defines a central longitudinal axis. The jawassembly extends distally from the elongate shaft. The jaw assembly hasa proximal end pivotably coupled to the elongate shaft and a distal end.The jaw assembly comprises a first jaw and a second jaw. The first jawhas a proximal end pivotably coupled to the elongate shaft and a distalend having a first needle retention slot therein. The second jaw has aproximal end pivotably coupled to the elongate shaft and a distal endhaving a second needle retention slot therein. The first shim extendsdistally to a distal end positioned in the first jaw and the second shimextends distally to a distal end positioned in the second jaw. Thetoggle mechanism is operable in a toggle cycle to alternatelylongitudinally advance the distal end of the first shim adjacent thefirst needle retention slot and advance the distal end of the secondshim adjacent the second needle slot.

In certain embodiments, a laparoscopic suturing device is providedherein. The laparoscopic suturing device comprises a handle assembly, anelongate shaft, and a jaw assembly. The handle assembly has a proximalend and a distal end. The handle assembly comprises a latch mechanismhaving a latched configuration and an unlatched configuration. Theelongate shaft extends distally from the distal end of the handleassembly and defines a central longitudinal axis. The jaw assemblyextends distally from the elongate shaft. The jaw assembly has aproximal end pivotably coupled to the elongate shaft and a distal end.The jaw assembly comprises a first jaw and a second jaw. The first jawcomprises a first base jaw and a first flip jaw. The first base jaw isat the proximal end of the jaw assembly. The first flip jaw is at thedistal end of the jaw assembly and pivotably coupled to the first basejaw. The first flip jaw is pivotable between a stowed position defininga low diametric profile of the jaw assembly and a suturing position. Thesecond jaw comprises a second base jaw and a second flip jaw. The secondbase jaw is at the proximal end of the jaw assembly pivotably coupled tothe first base jaw and the elongate shaft. The second flip jaw is at thedistal end of the jaw assembly and pivotably coupled to the second basejaw. The second flip jaw is pivotable between a stowed position defininga low diametric profile to the jaw assembly and a suturing position. Thelatch mechanism is operably coupled to the first flip jaw and the secondflip jaw such that with the latch mechanism in the latched position, thefirst flip jaw and the second flip jaw are maintained in the stowedposition and with the latch mechanism in the unlatched position, thefirst flip jaw and the second flip jaw are pivotable to the suturingposition.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of an embodiment of jaw assembly for alaparoscopic suturing device in a stowed configuration;

FIG. 2 is a side view of the jaw assembly of FIG. 1;

FIG. 3 is a top plan view of the jaw assembly of FIG. 1;

FIG. 4 is a side view of the jaw assembly of FIG. 1 with the base jawsin an open state and flip jaws in the stowed configuration;

FIG. 5 is a side view of the jaw assembly of FIG. 1 with the base jawsin an open state and flip jaws partially rotated to a suturingconfiguration;

FIG. 6 is a side view of the jaw assembly of FIG. 1 with the base jawsin an open state and flip jaws rotated to a suturing configuration;

FIG. 7 is a side view of one jaw of the jaw assembly of FIG. 1 with asuturing needle disposed therein;

FIG. 8 is a top view of the jaw of FIG. 7;

FIG. 9 is an isometric view of the jaw of FIG. 7 with the suturingneedle disposed therein;

FIG. 10 is a cross-sectional view of a flip jaw and suturing needle ofthe jaw of FIG. 7;

FIG. 11 is a lower plan view of a flip jaw for the jaw of FIG. 7

FIG. 12 is an exploded view of the jaw of FIG. 7;

FIG. 13 is a top plan view of the jaw of FIG. 7 with a section linethereon;

FIG. 14 is a cross sectional view about the section line of the jaw ofFIG. 7 in a suturing configuration;

FIG. 15 is a cross sectional view about the section line of the jaw ofFIG. 7 partially rotated to a stowed configuration;

FIG. 16 is a cross sectional view about the section line of the jaw ofFIG. 7 partially rotated to a stowed configuration;

FIG. 17 is a cross sectional view about the section line of the jaw ofFIG. 7 rotated to the stowed configuration;

FIG. 18 is a cross sectional view about the section line of the jaw ofFIG. 7 in a suturing configuration;

FIG. 19 is a cross sectional view about the section line of the jaw ofFIG. 7 in a suturing configuration with a shim partially advanced tolock the flip jaw;

FIG. 20 is a cross sectional view about the section line of the jaw ofFIG. 7 in a suturing configuration with a shim advanced to latch theflip jaw and retain the suturing needle;

FIG. 21 is a perspective view of the flip jaw and needle of the jaw ofFIG. 7 with a section plane illustrated in broken lines;

FIG. 22 is a cross sectional view of the flip jaw and needle of FIG. 21about the section plane;

FIG. 23 is a side view of the flip jaw and needle of FIG. 21;

FIG. 24 is a perspective view of the flip jaw and needle of FIG. 21 withan actuation cable attached thereto;

FIG. 25 is an exploded view of an embodiment of jaw assembly and anactuation assembly for a laparoscopic suturing device;

FIG. 26 is a perspective view of base jaws of the jaw assembly of FIG.25 in an open configuration;

FIG. 27 is a perspective view of base jaws of the jaw assembly of FIG.25 in a closed configuration;

FIG. 28 is an end view of an embodiment of suturing needle for use in alaparoscopic suturing device;

FIG. 29 is a side view of the suturing needle of FIG. 28;

FIG. 30 is an isometric view of a base jaw of the jaw of FIG. 7;

FIG. 31 is a perspective view of a clevis of the actuation assembly ofFIG. 25;

FIG. 32 is a perspective view of the clevis of FIG. 31 with a sectionplane illustrated in broken lines;

FIG. 33 is a cross sectional view of the clevis of FIG. 31 about thesection plane;

FIG. 34 is a perspective view of the jaw assembly and actuation assemblyof FIG. 25 with the clevis removed;

FIG. 35 is a perspective cross sectional view of the jaw assembly andactuation assembly of FIG. 34;

FIG. 36 is a cross sectional side view of the jaw assembly and actuationassembly of FIG. 34;

FIG. 37 is a cross sectional side view of the distal end of the jawassembly of FIG. 1 in the stowed configuration;

FIG. 38 is an isometric view of an embodiment of a slotted actuator ofthe actuation assembly of FIG. 25;

FIG. 39 is a top view of the slotted actuator of FIG. 38;

FIG. 40 is a side view of the slotted actuator of FIG. 38;

FIG. 41 is an isometric view of an embodiment of suturing device havingthe jaw assembly of FIG. 1;

FIG. 42 is a partially exploded view of an embodiment of handle assemblyof the suturing device of FIG. 41;

FIG. 43 is an exploded view of the handle assembly of FIG. 42;

FIG. 44 is a cross sectional top view of the handle assembly of FIG. 42;

FIG. 45 is a cross sectional side view of the handle assembly of FIG.42;

FIG. 46 is a partial cross sectional view of the suturing device of FIG.41 in an open configuration with a top cross sectional view of thehandle assembly;

FIG. 47 is a partial cross sectional view of the suturing device of FIG.41 in a partially-closed configuration with a top cross sectional viewof the handle assembly;

FIG. 48 is a partial cross sectional view of the suturing device of FIG.41 in a closed configuration with a top cross sectional view of thehandle assembly;

FIG. 49 is a partial cross sectional view of the suturing device of FIG.41 in a closed configuration with a top cross sectional view of thehandle assembly;

FIG. 50 is a partial cross sectional view of the suturing device of FIG.41 in a partially closed configuration with a top cross sectional viewof the handle assembly;

FIG. 51 is a partial cross sectional view of the suturing device of FIG.41 in an open configuration with a top cross sectional view of thehandle assembly;

FIG. 52 is an isometric view of embodiments of toggling and latchmechanisms of the handle assembly of FIG. 41

FIG. 53 is a side view of the toggling and latch mechanisms of FIG. 52;

FIG. 54 is a top view of the toggling and latch mechanisms of FIG. 52;

FIG. 55 is a section view of the toggling mechanism of FIG. 52 with afollower in a first position during a toggle cycle;

FIG. 56 is a section view of the toggling mechanism of FIG. 52 with afollower in a second position during a toggle cycle;

FIG. 57 is a section view of the toggling mechanism of FIG. 52 with afollower in a third position during a toggle cycle;

FIG. 58 is a section view of the toggling mechanism of FIG. 52 with afollower in a fourth position during a toggle cycle;

FIG. 59 is a section view of the toggling mechanism of FIG. 52 with afollower in a fifth position during a toggle cycle;

FIG. 60 is a section view of the toggling mechanism of FIG. 52 with afollower in a first position after a completed toggle cycle;

FIG. 61 is a partial cross sectional view of the suturing device of FIG.41 in an open configuration with a side cross sectional view of thehandle assembly;

FIG. 62 is a partial cross sectional view of the suturing device of FIG.41 with flip jaws rotated by the latch mechanism to a partially stowedconfiguration with a side cross sectional view of the handle assembly;

FIG. 63 is a partial cross sectional view of the suturing device of FIG.41 with flip jaws rotated by the latch mechanism to a stowedconfiguration with a side cross sectional view of the handle assembly;

FIG. 64 is a cross sectional view of an embodiment of elongate shaft ofthe suturing device of FIG. 41;

FIG. 65 is a side view of an embodiment of the jaw assembly of asuturing device having a needle with a barbed suture and a braidedanchor; and

FIG. 66 is a side view of an embodiment of the jaw assembly of asuturing device having a needle with a barbed suture, a braided leader,and a braided anchor.

DETAILED DESCRIPTION OF THE INVENTION

In various embodiments, a suturing system is disclosed herein that canincrease a surgeon's efficiency at applying sutures to tissue inside apatient during minimally invasive surgeries such as laparoscopicsurgeries. The suturing device passes a needle with an attached sutureback and forth through tissue between alternate jaws of a jaw assemblyby driving the needle through tissue and using a receiving jaw to gripthe needle while a driving jaw releases the needle.

During clinical use, an access device such as a trocar is first placedthrough a body wall and into a body cavity, leaving the trocar cannuladisposed within the body cavity and across the body wall. The suturingdevices discussed herein can utilize a suture that is attached to thecenter of a needle with sharp points on both ends so it may be passedback and forth through tissue. In order to fit the device down arelatively low diameter trocar such as a 5 mm trocar, the needle can bestowed away during insertion and removal through the trocar in order tolower the diametric profile of the device. When the needle is stowedaway the device is considered to be in the deactivated or stowed state.When inside the body cavity or during needle loading outside the body,the device can be deployed into its activated or suturing state. Whilein its activated state, the device is able to drive a suturing needlethrough tissue and pass the needle and attached suture from a drivingjaw to the receiving jaw.

Advantageously, the stowed needle configuration of the devices hereincan allow the use of a needle with a length that otherwise would not fitdown a 5 mm trocar. Allowing the surgeon to use a smaller trocar hasconsiderable advantages, such as reducing post-operative healing timeand scarring of the patient. Larger common size of trocars such as 10mm, 12 mm and 15 mm would require a significantly larger incision than a5 mm trocar. The stowed configuration of the devices herein obviatesneedle-length limitations of conventional suturing devices. The devicesdescribed herein can therefore stitch using a longer needle than theconventional 10 mm trocar diameter suturing devices while being able totraverse through a 5 mm trocar. This use of a longer needle canadvantageously allow more tissue or thicker tissue to be penetrated,allowing the surgeon to suture more than 10 mm devices allow.

With reference to FIGS. 1-6, various aspects of an embodiment of adistal end of a laparoscopic suturing device 10 including an elongateshaft 50 and a jaw assembly 100 are illustrated. FIGS. 1-3 illustrateisometric, side, and top views of the jaw assembly 100 in a stowedconfiguration retaining a needle 200 and suture 220. In the stowedconfiguration, the jaw assembly 100 has a relatively small outerdiameter for insertion through a laparoscopic surgical port such as atrocar cannula. As illustrated, with the jaw assembly in the stowedconfiguration, the needle 200 is retained by one of the jaws 110, 160and the suture 220 extends proximally from the needle along the elongateshaft 50.

In certain embodiments, the jaw assembly 100 can be sized for insertionthrough one of a number of trocar cannula sizes, such as a trocarcannula for receiving 5 mm instruments, 10 mm instruments, 12 mminstruments, or 15 mm instruments. Advantageously, the suturing deviceherein having a low profile stowed jaw assembly configuration can allowa relatively large needle to be deployed through an instrument sized fora relatively small trocar.

With continued reference to FIGS. 1-3, in the illustrated embodiment,the jaw assembly 100 comprises a first jaw 110 and a second jaw 160 eachhaving a proximal end pivotably coupled to one another and to a distalend 52 of the elongate shaft 50. The first jaw 110 can comprise a firstbase jaw 120 having a proximal end pivotably coupled to the elongateshaft 50 and a distal end. The first jaw 110 can further comprise afirst flip jaw 140 pivotably coupled to the distal end of the first basejaw 120. In the illustrated embodiment, similarly, the second jaw 160can comprise a second base jaw 170 having a proximal end pivotablycoupled to the elongate shaft 50 and a distal end with a second flip jaw190 pivotably coupled thereto.

With reference to FIGS. 4-6, further aspects of an embodiment of jawassembly 100 of the laparoscopic suturing device 10 are illustrated. InFIGS. 4-6, side views of a sequence of operation of the jaw assemblyfrom the stowed configuration to a suturing configuration areillustrated. FIG. 4 illustrates the jaw assembly 100 with the jaws 110,160 having their base jaws 120, 170 in an open position pivoted suchthat their distal ends are spaced apart from one another and their flipjaws 140, 190 pivoted to a stowed configuration. As further discussedherein with reference to FIGS. 61-63, a latch mechanism can be actuatedby a user to pivot the flip jaws 140, 190 from the stowed configuration(FIG. 4) through a partially-rotated position (FIG. 5) to a suturingconfiguration (FIG. 6).

With reference to FIGS. 7-12, various aspects of a first jaw 110 of anembodiment of jaw assembly 100 and a needle 200 are illustrated. FIGS.7-9 illustrate side, top and isometric views of the first jaw 110 withthe first flip jaw 140 in the suturing configuration with the needle 200positioned therein. A proximal end of the first base jaw 120 cancomprise a pivot 124 such as an aperture therethrough to receive a rivetor pinned connection with the second jaw 160 and the distal end 52 ofthe elongate shaft 50. The proximal end of the first base jaw 120 canfurther comprise an actuation post 126 such that the first base jaw 120can be pivoted about the pivot 124 by actuation of the post 126 by a jawactuation mechanism. The first base jaw has a jaw body extendingdistally from the pivot 124 to a distal end. The first flip jaw 140 ispivotably coupled to the distal end of the first base jaw 120.

With reference to FIG. 10, a cross sectional view of the distal end ofthe first jaw 110 is illustrated. The first flip jaw 140 can have aneedle receiving channel 142 formed therein. With the first flip jaw 140pivoted to the suturing position, the needle receiving channel 142 ispositioned generally transverse to a longitudinal axis of the first basejaw 120 to align with a curvature of the needle. Additionally, withreference to FIG. 11, the needle receiving channel 142 can have anoblong or eccentric cross sectional profile to maintain a rotationalorientation of the needle 200 with respect to the needle receivingchannel 142.

With continued reference to FIG. 10, in some embodiments, to increasemanufacturability, the flip jaw's needle receiving channel can be astraight hole to allow the use of a non-rotating core pin duringinjection molding. The straight hole can be angled to be tangent to acircle drawn about the base jaw pivot centerline. The core pin can beinserted at an angle to account for a curvature of the needle. The corepin hole can be elliptical or an elongated oval to minimize the abilityof the curved needle to rotate while seated in the hole. The major axisof the elliptical cross section can be oriented in the direction of theneedle bend to account for the curvature of the needle. In a sectionview going through the needle hole of the flip jaw in the direction ofthe needle curvature, the needle can have three contact points toprevent motion. The width of the minor axis of the cross sectionalellipse would be the needle diameter plus clearance to prevent theneedle from twisting around its longitudinal axis while seated in thehole.

With reference to FIG. 12, an exploded view of an embodiment of thefirst jaw 110 is illustrated. In the illustrated embodiment, the firstflip jaw 140 is pivotably coupled to the first base jaw 120 with apinned connection. In some embodiments, the first flip jaw 140 can bebiased to the suturing position by a biasing member such as a torsionspring 144 positioned about a rotational axis of the flip jaw 140between the flip jaw 140 and the base jaw 120. A first cable 390 and afirst shim 360 can extend through a slot in the first base jaw 120 tothe first flip jaw 140 to be selectively actuated by a user in anoperation sequence through operation of a latching mechanism and togglemechanism as further described below.

With reference to FIGS. 14-17, cross sectional views of an embodiment offirst jaw 110 about a section line illustrated in FIG. 13 areillustrated. FIGS. 14-17 illustrate an operating sequence of the firstflip jaw 140 during operation of the latching mechanism such that thefirst flip jaw is pivoted from the suturing configuration (FIG. 14)through partially-stowed configurations (FIGS. 15-16) to the stowedconfiguration (FIG. 17). Operation of the latch mechanism can increasetension on the first cable 390 extending through a slot or channelformed longitudinally in the first base jaw 120 to pivot the first flipjaw 140 relative to the first base jaw. While the first torsion spring144 (FIG. 12) can be used to bias the first flip jaw 140 to a suturingconfiguration once the suturing device has been introduced to a surgicalfield, it is contemplated that following use of the suturing device, atensioned cable can advantageously provide reliable, robust rotation ofthe flip jaw 140 to the stowed position even where accumulation of fluidor tissue may otherwise resist or prevent rotation of the flip jaw. Inother embodiments, the torsion spring 144 can be replaced with anadditional cable such that the latching mechanism utilizes a first cableto pivot the flip jaw to a suturing configuration in an unlatchingoperation and the illustrated cable to pivot the flip jaw to the stowedconfiguration in the latching operation.

FIGS. 18-20 illustrate cross-sectional views of the first jaw 110 in anoperating sequence of the toggle mechanism to advance a distal end ofthe first shim 360 distally through a slot or shim channel 141 in thefirst flip jaw 140. Distal advancement of the first shim 360 through theshim channel 141 extending through the first flip jaw 140 (FIG. 19)locks the first flip jaw 140 in the suturing configuration. The shimchannel 141 can traverse the needle receiving channel. With the needle200 positioned in the needle receiving channel 142, a shim notch 210 ofthe needle is generally aligned with the shim channel 141 of the firstflip jaw 140. Accordingly, further advancement of the first shim 360extends the shim distally to engage an interference feature such as afirst slot or shim notch 210 (FIGS. 28-29) in the needle 200 to latchthe needle 200 into the first flip jaw (FIG. 20). The shim channel 141in the first flip jaw 140 can extend distally beyond the needlereceiving channel 142 such that the first shim can engage the first flipjaw 140 proximal and distal of the needle receiving channel 142 and berecessed from tissue. In some embodiments, a distal surface of the firstflip jaw 140 can include a protrusion formed thereon having the slottherein to allow additional distal movement of the first shim 360. Whilethe illustrated embodiment includes a single shim to lock both the flipjaw and needle, in other embodiments, it is contemplated that locking ofthe needle and flip jaw can be accomplished using two separatemechanisms. In these embodiments, a shim can be used to lock the needle,and the flip jaw may be locked by another mechanism such as a secondshim, sliding bolt, or pin.

With reference to FIGS. 21-24, various views of the first flip jaw 140,needle 200 and first shim 360 (FIGS. 21-22) are illustrated. FIG. 22illustrates a sectional view of the first flip jaw about the sectionalplane indicated in broken lines in FIG. 21 with the shim 360 partiallyadvanced into the shim channel 141 in the first flip jaw 140. The firstflip jaw can include a retention feature such as a generally sphericaldetent 146 positioned therein to engage a corresponding mating recess214 in the needle 200. This detent engagement can advantageouslymaintain the position of the needle 200 within the flip jaw when thefirst flip jaw 140 is in the stowed configuration and before the togglemechanism has completely advanced the first shim 360 to engage the firstshim notch 210 of the needle. In some embodiments, the detent can have aleaf spring wrapped around the flip jaw that applies force to a ball.The ball can reside inside a cylindrical channel that intersects withthe needle hole in the flip jaw. The channel narrows near the needlehole to prevent the ball from falling out when no needle is present.When a needle is in the flip jaw, the ball is pressed into acorresponding recess in the needle to retain it while the shims are notlocking the needle in place. In other embodiments, instead of the ballof the illustrated embodiment, the needle detent of the flip jaw can bean elastomeric protrusion, a shaped leaf spring tab, or a magnet.

FIG. 23 illustrates the first torsion spring 144 positioned about thepivot axis of the first flip jaw 140. The illustrated embodiment offirst flip jaw 140 also includes the distal protrusion beyond the needleretention channel. As illustrated, one portion of the distal surface ofthe first flip jaw 140 protrudes from an otherwise generally planar faceand includes the shim slot therethrough. An adjacent portion of thedistal surface of the first flip jaw is recessed such that the firstflip jaw 140 can be nested with the second flip jaw in a low profileconfiguration having a relatively small outer diameter with the jawassembly in the stowed configuration.

FIG. 24 illustrates the first cable 390 of the latch mechanism coupledto the first flip jaw. The first cable 390 is coupled to the first flipjaw at a location offset from the pivot axis such that tension in thecable tends to pivot the first flip jaw towards the stowedconfiguration. The first flip jaw 140 can include a cable slot in anouter surface thereof to receive the first cable 390 when the first flipjaw 140 has been pivoted to the suturing configuration.

With reference to FIG. 25, an exploded view of a distal end oflaparoscopic suturing device 10 is illustrated. As illustrated, thedistal end includes the jaw assembly 100, a jaw actuation mechanism 150,and a distal end 52 of an elongate shaft 50. In the illustratedembodiment, the jaw assembly includes first and second jaws 110, 160that are pivotably coupled to one another and are substantially similar.It is contemplated that in other embodiments of jaw assembly for use inthe suturing device herein, a suturing device can include jaws havingdifferent configurations. For example, a jaw assembly can include asingle pivotable jaw and a single stationary jaw or only one jaw havinga pivotable flip jaw. Thus, in some embodiments, a jaw assembly caninclude a first jaw comprising a first base jaw and a first flip jawpivotably coupled to the first base jaw in which the needle can bepositioned in a stowed configuration, and a second jaw pivotably coupledto the distal end of the elongate shaft, but having a needle recesstherein with no corresponding second flip jaw. In other embodiments, thesecond jaw can extend longitudinally distally from the elongate shaftand be pivotably fixed relative to the elongate shaft.

With continued reference to FIG. 25, the jaw actuation mechanism 150 caninclude a clevis 152 and an actuator 154. The clevis 152 can containguiding slots for the shims and cables to prevent buckling. A slottedhead of the actuator 154 can support the shims and cables fromunderneath to prevent buckling inside the clevis. The clevis can beformed at or positioned on the distal end 52 of the elongate shaft 50.The first and second jaws can be pivotably coupled to the clevis 152.The slotted head of the actuator 154 can include actuation slots 156formed therein. In the illustrated embodiment, a drive rod 158 isslideable within the elongate shaft 50 and is coupled to the actuator154 to advance the actuator 154 proximally and distally relative to theelongate shaft 50. Actuation posts 126 of the first and second base jaws120, 170 can be positioned within the actuation slots 156 such thatlongitudinal translation of the actuator 154 opens and closes the basejaws 120, 170.

FIGS. 26-27 illustrate the actuator 154, first base jaw 120, and secondbase jaw 170. As illustrated, the actuator 154 can be translatedlongitudinally to pivot the base jaws 120, 170 relative to one anothersuch that the base jaws 120, 170 can be selectively positioned in anopen (FIG. 26) or closed (FIG. 27) configuration.

With reference to FIGS. 28-29, an embodiment of suturing needle isillustrated. As illustrated, the needle 200 includes a first shim notch210 adjacent a first penetrating tip, a second shim notch 212 adjacent asecond penetrating tip, a first recess 214 adjacent the firstpenetrating tip, and a second recess 216 adjacent the second penetratingtip. By alternating which shim is locking the needle, the needle may bepassed between the two jaws of the device. Advantageously, the needlealso has detent features provided by the first and second recesses 214,216 that allow the jaws to grip the needle while there are no shimslocking the needle in place (i.e. in the stowed configuration). Theneedle can also include an aperture 218 for receiving a suturetherethrough. It is contemplated that in some embodiments, the suturecan include a leader segment such as a braided metallic or polymericsegment coupled to the needle 200 at the aperture 218 and a suturingsegment coupled to the leader such as at a crimp joint. In variousembodiments, the leader segment can be knotted, adhered with adhesive,heat forming, or tied about the needle. In various embodiments, theleader segment and suturing segment can be fixed by knotting the sutureand leader, heat forming the suture and leader inside, or adhered withadhesive. The suturing segment can be a monofilament polymeric suture.

Desirably, this suture construction with a braided leader andmonofilament suturing segment can be resilient and enhance usability.Driving the needle through tissue can cause repeated bending of theleader at the needle/leader interface. Having a more flexible materialcan reduce the likelihood of breakage due to repeated bending of thematerial at this interface. This flexibility also decreases the amountof force to drive the needle through tissue since the material bendseasier and therefore reduces the profile. In some embodiments, theleader can be inserted into the needle aperture, and then crimped in theaperture. The leader can be connected to the suture by a stainless steelcrimped tube. The suture may also be braided to increase flexibility. Insome embodiments, the leader can be braided stainless steel to desirablyprovide enhanced strength and allow welding to the needle.

In some embodiments, the suturing segment can comprise a monofilament orbraided suture that is unidirectionally barbed to prevent it fromretracting through the tissue and causing wound dehiscence. Thisretention feature would eliminate the need for the surgeon to tie knotsafter every stitch, which improves the efficiency and ease of thesurgery. An end of the suture opposite the needle can have an anchor toprevent further migration into the tissue and wound dehiscence. In someembodiments, the anchor can comprise a fixed or variable diameter loopthat the suture is threaded through after the first pass through tissue,resulting in a knotless anchored end. The suturing is then continuedwithout the need to tie any knots. In other embodiments, the anchor ofthe suture can comprise a T-shaped anchor. Desirably, a T-shaped anchorcan eliminate the need for threading the suture through an anchor loopafter the first pass through tissue.

With continued reference to FIG. 29, in the illustrated embodiment, theneedle can comprise a double headed configuration with penetrating tipsdisposed at opposite ends thereof. A central body of the needle can begenerally curved. In some embodiments, the needle is curved to have abend radius that is equal to the distance from the needle to the basejaw's pivot centerline. This bend radius can help guide the needlethrough tissue and can minimize the amount of torque that could bend theneedle during the piercing of tissue. In other embodiments, the needlecan comprise a single headed configuration with a single penetrating tipdisposed at one end thereof.

With reference to FIGS. 30-33, an embodiment of first base jaw 120 (FIG.30) and an embodiment of clevis 152 are illustrated. As illustrated,both the base jaws 120, 170 and clevis 152 can include passages such aslongitudinal slots or channels to facilitate operation of the shims andcables.

With reference to FIGS. 34-37, the jaw assembly 100 and jaw actuationmechanism 150 are illustrated with the jaw assembly in a stowedconfiguration with a needle 200 in one of the jaws. FIG. 37 illustratesthe needle 200 with a suture 220 having a leader 222, crimp 224, andsuturing segment 226 attached thereto.

With reference to FIGS. 38-40, an embodiment of actuator 154 for the jawactuation mechanism is illustrated. As illustrated, the actuatorcomprises a slotted actuation member having actuation slots 156 onopposing surfaces thereof. The slotted portion of the actuation membercan be positioned between the first base jaw and the second base jawproximal of the pivot such that actuation posts of the base jaws areeach received in an actuation slot 156.

With reference to FIG. 41, an embodiment of laparoscopic suturing device10 is illustrated. The suturing device 10 can include a handle assembly300, an elongate shaft 50, and a jaw assembly 100. The handle assemblycan extend generally longitudinally from a proximal end to a distal end.The handle assembly 300 can include a trigger mechanism 310 includingpivotable levers protruding from the handle assembly. In otherembodiments, it is contemplated that other handle and triggerconfigurations can be used with various aspects of jaw assemblymechanism described herein. The elongate shaft 50 extends distally fromthe distal end of the handle assembly and defines a central longitudinalaxis of the suturing device 10. The jaw assembly 100 can include a pairof opposing jaws pivotably coupled to one another and to the distal end52 of the elongate shaft 50.

With reference to FIGS. 42-43, an embodiment of handle assembly isillustrated in partially exploded and fully exploded view. In FIG. 42, ahandle housing has been removed to illustrate a trigger mechanism 310,closure mechanism 340, toggle mechanism 350, and latch mechanism 380therein. In FIG. 43, the trigger mechanism 310, closure mechanism 340,toggle mechanism 350, and latch mechanism 380 are illustrated in anexploded arrangement.

With reference to FIGS. 44-45, cross sectional views of an embodiment ofhandle assembly are illustrated. FIG. 44 illustrates a top crosssectional view. FIG. 45 illustrates a side cross sectional view.

With reference to FIGS. 46-51, partial cross-sectional views of thehandle assembly are illustrated along with corresponding positions ofthe jaw assembly 100 and needle 200. FIG. 46 illustrates the handleassembly in an initial position with the needle 200 positioned in firstjaw 110. FIGS. 47-48 illustrate an operational sequence as first andsecond levers 312, 322 of the trigger mechanism are squeezed towards thehandle body of handle assembly 300. FIGS. 49-51 illustrate anoperational sequence as first and second levers 312, 322 of the triggermechanism 310 are released from the handle body of handle assembly 300.

With reference to FIGS. 46-48, the trigger mechanism can include a pairof opposed levers 312, 322 each pivotable with respect to the handlebody. As illustrated, the levers can be pivotably coupled to the handlebody adjacent a distal end of the handle assembly. Each of the levers312, 322 can comprise a drive slot 314, 324 formed therein. Asillustrated, the drive slots 314, 324 can include profiles configured toinitially close the jaws as the levers are squeezed, then maintainclosure upon further movement of the levers 312, 322 while the togglemechanism is actuated. For example, the drive slots 314, 324 can includea driving segment 316, 326 and a dwell segment 318, 328. A closuremechanism 340 can include posts guided by the drive slots 314, 324 andcoupled to a proximal end of the drive rod 342, which extends distallythrough elongate shaft 50 to the jaw actuation mechanism 150.Accordingly, upon initial movement of the levers 312, 322 toward handlebody, (FIGS. 46-47), posts 344 are guided through driving segments 316,326 of drive slots 314, 324 to longitudinally translate drive rod 342and close base jaws 120, 170 (FIG. 47).

With reference to FIGS. 47-48, further compression of the levers 312,322 towards handle body results in posts 344 of the closure mechanismmoving in dwell segments 318, 328 of drive slots 314, 324, resulting inminimal further displacement of drive rod 342. However, the levers 312,322 of trigger mechanism are each pivotally coupled to first ends ofactuation links 320, 330 extending generally proximally within thehandle assembly. Second ends of the actuation links 320, 330 oppositethe first ends are coupled to a drive pusher 352 that is longitudinallytranslatable within the handle body. Longitudinal translation of thedrive pusher 352 within the handle body can actuate the toggle mechanism350 to selectively rotate a toggle tube 354 within the handle body asfurther described with reference to FIGS. 52-60.

With reference to FIGS. 46-48, an initial compression of the levers 312,322 of trigger mechanism (FIGS. 46-47) actuates actuation links 320, 330to translate the drive pusher 352 proximally along the toggle tube 354of the toggle mechanism 350. Further compression of the levers 312, 322of the trigger mechanism actuates actuation links 320, 330 to translatedrive pusher proximally along the toggle tube 354 and rotate the toggletube about a longitudinal axis of the handle body. As further describedherein with reference to FIGS. 52-60, rotation of the toggle tube 354alternately longitudinally advances one of the first shim 360 and thesecond shim 370 to retain the needle 200 alternately in one of the firstand second jaws. Thus, when a user squeezes the levers 312, 322 of thetrigger mechanism, the jaws of the jaw assembly are closed, and theneedle 200 is passed from one jaw to another.

With reference to FIGS. 49-51, releasing the levers 312, 322 guides theposts 344 of the closure mechanism 340 along the dwell segments 318, 328of the slots 314, 324 (FIGS. 49-50). During this initial openingmovement, the toggle tube 354 continues to rotate, completing theadvancement of one of the shims. As the levers continue to spread, theposts 344 of the closure mechanism 340 ride along the driving segments316, 326 of the slots 314, 324 (FIGS. 50-51) such that the drive rod 342is longitudinally translated to return the jaw assembly to an openconfiguration. This further movement translates the drive pusher 352distally along toggle tube 354 of toggle mechanism 350.

With reference to FIGS. 52-54, various aspects of the toggle mechanismare illustrated in isometric, top, and side views. As illustrated, thetoggle mechanism 350 comprises a drive pusher 352 longitudinallyslideable within the handle body by actuation of the trigger mechanism310. The drive pusher 352 can include a forked proximal end having afollower 353 such as a post protruding from each fork of the drivepusher 352. While the drive pusher 352 is illustrated as amonolithically formed component, in other embodiments, fork arms of thepusher could be discrete parts that function in a similar fashion. Insome embodiments, the arms of the pusher can be rigid with a translatingpin and spring element keeping the pin in contact with the toggle tube.The toggle mechanism 350 can also include a toggle tube 354 rotatablewithin the handle body. As illustrated, the toggle tube 354 comprises acam drive slot 356 and a shim guide 358. The followers 353 of the drivepusher can be positioned in the cam drive slot 356. The cam drive slot356 can include a pair of generally longitudinally extending leadsegments and a rotation segment extending at an angle transverse to alongitudinal axis of the handle body between the lead segments.

With continued reference to FIGS. 52-54, the toggle mechanism 350 canfurther comprise a first shim 360 having a first follower 362 at aproximal end thereof and a second shim 370 having a second follower 372at a proximal end thereof. The followers 362, 372 can compriseprotruding posts extending radially inwardly from the shims 360, 370.Each of the followers 362, 372 can be positioned in the shim guide 358of the toggle tube 354. In other embodiments, the shims can includeradially inwardly extending flanges positioned in the shim guide to movethe shims without followers. The shim guide 358 can have a shimadvancement profile such that rotation of the toggle tube 354 within thehandle body alternately longitudinally advances or retracts thefollowers 362, 372 of the shims 360, 370. Thus, rotation of the toggletube 354 in a toggle cycle can alternately advance and retract the shims360, 370 to alternately retain the needle within one or the other of theflip jaws as described with reference to FIGS. 18-20.

With reference to FIGS. 55-60, an operational sequence of the togglemechanism is illustrated in sectional views. In FIG. 55, the follower353 of the drive pusher 352 is positioned in the longitudinal leadsegment of the cam drive slot 356, the first shim 360 is in a distallyadvanced position, and second shim 370 is in a retracted position.During an initial squeezing operation of the trigger mechanism,corresponding to closing the jaw assembly as described above withreference to FIGS. 46-47, the follower 353 is advanced longitudinallyproximally along the lead segment of the cam drive slot 356, asillustrated in FIGS. 55-56. The toggle tube 354 is not rotated duringthis operation, and the first and second shims 360, 370 remain in theirinitial positions.

With reference to FIGS. 56-58, during the operational sequence of thetoggle mechanism 350, once the trigger mechanism is squeezed beyond jawclosure (FIGS. 47-48), the follower 353 of the drive pusher 352 reachesthe rotation segment of the cam drive slot 356. The rotation segment canbe configured to rotate the toggle tube 354 a predetermined directionupon actuation by the drive pusher 352. For example, the rotationsegment can have a variable depth profile at an intersection of therotation segment with the lead segment such that as the follower 353 isadvanced into rotation segment, it tends to follow a desired segment ofthe rotation segment to rotate the toggle tube a predetermineddirection. The rotation segment extends along the toggle tube 354transverse to a longitudinal axis of the handle body such that furtherproximal advancement of the drive pusher 352 and follower 353 relativeto the toggle tube rotates the toggle tube 354 within the handle body(FIGS. 56-58). This rotation of the toggle tube 354 likewise rotates theshim guide 358 such that the first shim follower 362 and first shim 360are withdrawn proximally while second shim follower 372 and second shim370 are advanced distally. Thus, during a continued squeezing operationof the trigger mechanism, corresponding to closing the jaw assembly asdescribed above with reference to FIGS. 47-48, the follower 353 isadvanced along the rotation segment of the cam drive slot 356, asillustrated in FIGS. 56-58. The toggle tube 354 is rotated during thisoperation, and the first and second shims 360, 370 are longitudinallymoved.

With reference to FIGS. 58-60, during the operational sequence of thetoggle mechanism 350, once the trigger mechanism is released from afully squeezed orientation (FIGS. 49-51), the follower 353 of the drivepusher 352 reaches a proximal-most peak of the rotation segment of thecam drive slot 356 (FIG. 58). The rotation segment can be configured tocontinue rotating the toggle tube 354 a predetermined direction uponrelease of the trigger mechanism and distal movement of the drive pusher352. For example, the rotation segment can have a variable depth profileat the proximal-most peak of the rotation segment such that as thefollower 353 is advanced along the rotation segment, it tends to followa desired segment of the rotation segment to rotate the toggle tube apredetermined direction. Furthermore, the follower 353 can be disposedat an end of a flexible arm on the drive pusher, which acts as a leafspring allowing the follower 353 to advance over a depth step. Therotation segment extends along the toggle tube 354 transverse to alongitudinal axis of the handle body such that initial distal withdrawalof the drive pusher 352 and follower 353 relative to the toggle tubecontinues to rotate the toggle tube 354 within the handle body (FIGS.58-59). Advantageously, this continued rotation is provided by a “doubleaction” stroke of the toggle tube (i.e. rotation during both squeezingand releasing the trigger mechanism). This double action strokedesirably halves the stroke length of the trigger mechanism that wouldotherwise be required to rotate the toggle tube and allows for a lowerpressure angle of the follower 353 and cam drive slot 356 system. Thisrotation of the toggle tube 354 likewise rotates the shim guide 358 suchthat the first shim follower 362 and first shim 360 are withdrawnproximally while second shim follower 372 and second shim 370 areadvanced distally. Thus, during an initial release operation of thetrigger mechanism, corresponding to the initial dwell portion asdescribed above with reference to FIGS. 49-50, the follower 353 isadvanced along the rotation segment of the cam drive slot 356, asillustrated in FIGS. 58-59. The toggle tube 354 is rotated during thisoperation, and the first and second shims 360, 370 continue to movelongitudinally until the second shim 370 reaches a distally advancedposition and the first shim reaches a proximally withdrawn position.

With reference to FIG. 60, during the operational sequence of the togglemechanism 350, as the trigger mechanism continues to travel to a fullyreleased position (FIGS. 50-51), the follower 353 of the drive pusher352 reaches the longitudinal lead segment of the cam drive slot 356(FIG. 60). The rotation segment can have a variable depth profile at theintersection of the rotation segment with the lead segment such that asthe follower 353 is withdrawn proximally, it tends to enter the leadsegment. Thus continued distal withdrawal of the drive pusher 352 andfollower 353 relative to the toggle tube along thelongitudinally-extending lead segment maintains the rotationalorientation of the toggle tube 354 within the handle body (FIG. 60).Thus, during a fully released operation of the trigger mechanism,corresponding to the jaw opening portion as described above withreference to FIGS. 50-51, the follower 353 is advanced along the leadsegment of the cam drive slot 356, as illustrated in FIG. 60. Duringthis operation, the second shim 370 remains in the distally advancedposition and the first shim 360 remains in the proximally withdrawnposition.

Accordingly, in the illustrated embodiment, one compress and releasecycle of the trigger mechanism cycles the toggle mechanism 350 to rotatethe toggle tube 354 180 degrees. This rotation of the toggle tube 354180 degrees repositions one shim 360 from a distally advanced positionto a proximally withdrawn position and repositions the other shim 370from a proximally withdrawn position to a distally advanced position.Thus, advantageously, the illustrated toggle mechanism can allow asingle trigger mechanism to actuate both a jaw open/close/open cycle andalternately advance a shim to retain a needle in one of the jaws. Inother embodiments, other toggle mechanisms can be used to alternatelyadvance and withdraw shims responsive to a cycle of a trigger mechanism.

As discussed above, the flip jaws utilize a torsion spring and cablemechanism for rotation between the stowed and suturing configurations.The flip jaws rotate about a dowel pin that is held on either end of theflip jaw by the base jaw. In some embodiments, a distal end of the cableis welded to the bottom of a corresponding flip jaw and is controlled bya latch mechanism in the handle. In other embodiments, the cables can beattached to corresponding flip jaws by crimping each cable into a slotin the corresponding flip jaw, or having a fitting on the end of eachcable that attaches to the corresponding flip jaw. In other embodiments,the flip jaw cable can also be fixed to the flip jaw by solder orbrazing. The torsion spring is on the flip jaw's rotation axis, betweenthe flip jaw and base jaw. The spring is biased to rotate the flip jawinto the activated, suturing configuration. To rotate the flip jaws tothe activated state, the tension in the cable is released to allow thetorsion springs to flip the jaws. To rotate the flip jaws into thedeactivated state, the cable is tensioned.

With reference to FIG. 61-63, an operational sequence of the latchmechanism 380 is illustrated. FIG. 61 illustrates the latch mechanism inan unlatched configuration corresponding to a suturing configuration ofthe flip jaws. The latch mechanism 380 can comprise a latch knob 381 ata proximal end of the handle assembly. In the illustrated embodiment,the latch knob 381 is coupled to a latch tube 382 having first andsecond guide slots 384, 386 formed therein. The latch mechanism furthercomprises first and second cables 390, 394 extending distally throughthe handle assembly and elongate shaft and coupled to the flip jaws ofthe jaw assembly as described above with respect to FIGS. 14-17.Proximal ends of the cables 390, 394 are coupled to posts 392, 396positioned within the guide slots 384, 386 of the latch tube 382. Theposts 392, 396 can be dowel pins protruding from a bearing tube that iscoupled to the toggle tube 354 of the toggle mechanism such thatproximal movement of the posts 392, 296 withdraws the toggle tube andshims 360, 370 proximally.

With continued reference to FIGS. 61-63, upon rotation of the latch knob381, latch tube 382 correspondingly rotates. Thus, posts 392, 396 arewithdrawn proximally by interaction with guide slots 384, 386 of guidetube. This proximal movement of posts 392, 396 applies tension to cables390, 394 to pivot flip jaws from the suturing configuration (FIG. 61) tothe stowed configuration (FIG. 63). This proximal movement of posts 392,396 also withdraws toggle tube 354 and shims 360, 370 proximally. Withthe latch mechanism 380 partially rotated, the shims 360, 370 can bewithdrawn from both jaws such that the jaw assembly can be reloaded witha new needle, if desired. Further rotation of the latch knob 381positions the posts 392, 396 at an end of the guide slots 384, 386 thatcan be configured, such as with a flat segment or detent, to maintainthe latch mechanism 380 in a latched configuration having the flip jawsin the stowed configuration.

When it is desired to unlatch the device to position the flip jaws inthe suturing configuration, the sequence of FIGS. 61-63 can be performedin reverse. In the unlatching sequence, the latch mechanism in thehandle both releases the cable tension and also slides the needlelocking shims forward in one motion. After the cable tension is releasedand the springs finish rotating the flip jaws to the activated state,the shims then slide forward into the flip jaws to prevent them fromrotating back into the deactivated state. One shim will slide further inorder to lock the needle in that jaw. In some embodiments, the latchmechanism can further comprise a tensioning spring to maintain tensionin the cables in both the latched and unlatched configurations of thesuturing device.

While a torsion spring biased unlatching and cable driven latchingoperation of the latching mechanism is illustrated, it is contemplatedthat in other embodiments, other latching mechanisms can be used withsuturing devices as described herein. For example, in some embodiments,each jaw can include a first cable to pivot the flip jaw to a suturingconfiguration and a second cable to pivot the flip jaw to a stowedconfiguration. In other embodiments, the flip jaws can be rotated orpushed into the suturing or stowed configurations using a more rigidcable or rod that can both push and pull the flip jaw, eliminating theneed for a torsion spring or two counteracting cables. In still otherembodiments, the flip jaws can be pivoted relative to the base jaws by aworm gear and sector, Nitinol actuators, or a lead screw and nut device.

With reference to FIG. 64, a cross section of the elongate shaftadjacent the distal end is illustrated. In the illustrated embodiment,the elongate shaft 50 can include a cover tube and a spacer member 56through which the drive rod, cables, and shims extend. In someembodiments, the spacer member can be an extruded member. The spacermember can prevent buckling of the shims, cables, and drive rod insidethe cover tube. When the user squeezes the levers of the triggermechanism, the levers transmit the force to the drive rod down thelength of the device's shaft.

With reference to FIGS. 65 and 66, in some embodiments, the needle 200and suture 420 can include a braided polymeric tube anchor 430. Thebraided polymer tube 430 can be disposed at an end of the sutureopposite the needle for use as an anchor for the suture. The braidedpolymer tube 430 anchor can be attached to the end of the suture viawelding, adhesive, or another joining method. Advantageously, thebraided polymer tube 430, with multiple insertion areas provided byvoids between adjacent areas of overlapping polymer strands, can providefor a relatively easy target for a surgeon to thread the needle through.

With reference to FIG. 66, in certain embodiments, the needle 200 andsuture 420 can include a leader segment 440 comprising a braided polymertube between the needle 200 and the suture 420. The braided polymerictube can allow for enhanced flexibility of the suture at the needleinterface.

With reference to FIGS. 65 and 66, in certain embodiments, the needleand suture 420 can include a unidirectional barbed suture to facilitateretention of tissue by the suture. In other embodiments, a smoothmonofilament suture can be used with a braided polymer tube anchorand/or braided polymer tube leader.

Suturing devices described herein can incorporate various materials andcombinations of materials in their construction. For example, in someembodiments, the flip jaws, base jaws, clevis, slotted head, drive rod,cables, torsion springs, shims, dowel pins, needle, detent spring,detent ball, cover tube, suture crimp, toggle tube, and rivet can bemade of metals such as stainless steel, aluminum, titanium, tungsten,brass, bronze, or alloys of such. In some embodiments, the shims and/orcables can be made out of Nickel-Titanium (Nitinol) to allow greaterflexibility and fatigue life. In some embodiments, the monofilament orbraided suture and flexible multifilament leader can be made ofnon-bioabsorbable polymers such as polypropylene, nylon, polyester, orsilk, or from bioabsorbable polymers such as polydioxanone, polylacticacid, polyglycolide, polylactic-co-glycolic acid, polycaprolactone, orcatgut. In some embodiments some or all of the trigger levers, linkages,latch, knob, shim followers, and drive rod adapters can be made ofplastics such as polycarbonate, ABS, polyethylene, polypropylene, PEEK,polyurethane, PVC, acrylic, nylon, polystyrene, acetal, carbon fiber,polyimide, or polyester.

While the illustrated embodiments of suturing device include a latchingmechanism to configure jaws to a stowed, low diametric profileconfiguration for insertion of a relatively large needle through arelatively low diameter surgical port, it is contemplated that in otherembodiments of suturing device, other configurations can achieve a lowdiametric profile for insertion. For example, in some embodiments, asuturing device can include a telescopically compressible needle. Acompression element such as a spring can be contained in the needle andenable two halves of the needle to concentrically compress whensubjected to forces greater than tissue puncturing. The closure of thejaws can be selectively controlled by the handle with one setting forpassage of the needle from jaw to jaw and another setting to enablefurther closure of the jaws to compress the needle to the low profilestate to enable withdrawal through a 5 mm trocar.

In the illustrated embodiment, the suture is positioned along theelongate shaft with the jaw assembly in a low-profile stowedconfiguration for insertion through a surgical port. It is contemplatedthat in other embodiments, the profile of the suturing device can befurther reduced for insertion. For example, in some embodiments, theclevis and outer tube of the elongate shaft can have an axial grooveformed therein for the suture to align in during insertion through atrocar, reducing the cross sectional profile of the device. In otherembodiments, suture can be coiled or folded within the two base jawsduring insertion through the trocar in order to reduce the crosssectional profile of the device. The base jaws can be closed around thecoiled or folded suture with the jaw assembly in the stowed state. Thebase jaws can then be opened while inside the body cavity to release thesuture. In other embodiments, the suturing device can further comprisean introducing tube in which the suture may be coiled or folded forinsertion through the trocar. This introducing tube can desirably reducethe cross sectional profile of the device during insertion through atrocar and allow the use of larger profile suture anchors. Theintroducing tube can cover the base jaws while they are fully closed inthe stowed configuration. Once inserted into the body cavity, anotherinstrument such as a surgical grasper can pull the introducing tube offthe jaws, releasing the suture inside the body cavity. The introducingtube can then be immediately removed from the body cavity through theother instrument's trocar.

Although this application discloses certain preferred embodiments andexamples, it will be understood by those skilled in the art that thepresent inventions extend beyond the specifically disclosed embodimentsto other alternative embodiments and/or uses of the invention andobvious modifications and equivalents thereof. Further, the variousfeatures of these inventions can be used alone, or in combination withother features of these inventions other than as expressly describedabove. Thus, it is intended that the scope of the present inventionsherein disclosed should not be limited by the particular disclosedembodiments described above, but should be determined only by a fairreading of claims which follow.

What is claimed is:
 1. A laparoscopic suturing system comprising: alaparoscopic suturing device comprising: a handle assembly; an elongateshaft having a proximal end coupled to the handle assembly and a distalend, and defining a central longitudinal axis extending between theproximal end and the distal end; and a jaw assembly coupled to thedistal end of the elongate shaft, the jaw assembly comprising a firstjaw and a second jaw each pivotably coupled to the elongate shaft andpivotable between an open configuration and a closed configuration; anda suturing needle positionable in the jaw assembly, the suturing needlecomprising: a needle having a generally curved profile and extendingfrom a first penetrating tip to a second penetrating tip, the needlecomprising: a first shim notch adjacent the first penetrating tip; asecond shim notch adjacent the second penetrating tip; a first recessadjacent the first penetrating tip; and a second recess adjacent thesecond penetrating tip; and a suture coupled to the needle.
 2. Thelaparoscopic suturing system of claim 1, further comprising a leadersegment coupling the suture to the needle.
 3. The laparoscopic suturingsystem of claim 1, further comprising an anchor segment coupled to thesuture.
 4. The laparoscopic suturing system of claim 1, wherein theanchor segment comprises a polymeric braided mesh.
 5. The laparoscopicsuturing system of claim 1, wherein the suture comprises a barbedmonofilament suture.
 6. The laparoscopic suturing system of claim 1,wherein the laparoscopic suturing device further comprises: a first shimlongitudinally advanceable in the first jaw and engageable with thefirst shim notch of the needle to retain the needle in the first jaw;and a second shim longitudinally advanceable in the second jaw andengageable with the second shim notch of the needle to retain the needlein the second jaw, and wherein the first shim and the second shim arealternately longitudinally advanceable to retain the needle alternatelyin one of the first and second jaws.
 7. The laparoscopic suturing systemof claim 1, wherein the first jaw further comprises a generallyspherical detent engageable with the first recess of the needle toretain the needle in the first jaw.
 8. The laparoscopic suturing systemof claim 1, wherein the needle is positionable in the jaw assembly adistance from the pivotable coupling of the first jaw and the second jawand wherein the generally curved profile of the needle has a bend radiusapproximately equal to the distance from the pivotable coupling.
 9. Alaparoscopic suturing system comprising: a laparoscopic suturing devicecomprising: an elongate shaft having a proximal end and a distal end,and defining a central longitudinal axis extending between the proximalend and the distal end; and a jaw assembly coupled to the distal end ofthe elongate shaft, the jaw assembly comprising: a first jaw comprisinga first base jaw having a proximal end and a distal end and a first flipjaw pivotably coupled to the distal end of the first base jaw; and asecond jaw comprising a second base jaw having a proximal end and adistal end and a second flip jaw pivotably coupled to the distal end ofthe second base jaw; wherein the proximal end of the first base jaw ispivotably coupled to the proximal end of the second base jaw and to theelongate shaft and wherein the first base jaw and the second base jaware pivotable between an open configuration and a closed configuration;and a suturing needle positionable in the jaw assembly, the suturingneedle comprising: a needle having a generally curved profile andextending from a first penetrating tip to a second penetrating tip; anda suture coupled to the needle.
 10. The laparoscopic suturing system ofclaim 9, wherein the first flip jaw is pivotable relative to the firstbase jaw between a stowed position and a suturing position, and whereinthe second flip jaw is pivotable relative to the second base jaw betweena stowed position and a suturing position.
 11. The laparoscopic suturingsystem of claim 10, wherein the jaw assembly further comprises: a firstspring biasing the first flip jaw to the suturing position; and a secondspring biasing the second flip jaw to the suturing position.
 12. Thelaparoscopic suturing system of claim 11, wherein the laparoscopicsuturing device further comprises: a first cable coupled to the firstflip jaw and actuatable to retain the first flip jaw in the stowedposition; and a second cable coupled to the second flip jaw andactuatable to retain the second flip jaw in the stowed position.
 13. Thelaparoscopic suturing system of claim 12, wherein the first cable andthe second cable extend proximally through the elongate shaft andwherein the laparoscopic suturing device further comprises a latchmechanism coupled to the first cable and the second cable, the latchmechanism positionable in a latched configuration to maintain tension inthe first cable and the second cable to retain the first flip jaw andthe second flip jaw in the stowed position.
 14. The laparoscopicsuturing system of claim 9, further comprising a first shim having aproximal end extending longitudinally in the elongate shaft and a distalend extending at least partially into the first jaw and a second shimhaving a proximal end extending longitudinally in the elongate shaft anda distal end extending at least partially into the second jaw.
 15. Thelaparoscopic suturing system of claim 14, wherein the distal end of thefirst shim is longitudinally slidable between a first position extendingthrough the first base jaw and withdrawn from the first flip jaw, asecond position extending through the first base jaw and partially intothe first flip jaw to maintain the first flip jaw in the suturingposition, and a third position extending through the first base jaw andinto the first flip jaw to maintain the first flip jaw in the suturingposition and engage the needle in the first flip jaw; and wherein thedistal end of the second shim is longitudinally slidable between a firstposition extending through the second base jaw and withdrawn from thesecond flip jaw, a second position extending through the second base jawand partially into the second flip jaw to maintain the second flip jawin the suturing position, and a third position extending through thesecond base jaw and into the second flip jaw to maintain the second flipjaw in the suturing position and engage the needle in the second flipjaw.
 16. The laparoscopic suturing system of claim 9, wherein the firstflip jaw and the second flip jaw are nestable into a low profileconfiguration having a relatively small outer diameter with the firstflip jaw and the second flip jaw each in the stowed configuration andthe first base jaw and the second base jaw in the closed configuration.17. A laparoscopic suturing system comprising: a laparoscopic suturingdevice comprising: an elongate shaft having a proximal end and a distalend, and defining a central longitudinal axis extending between theproximal end and the distal end; and a jaw assembly coupled to thedistal end of the elongate shaft, the jaw assembly comprising: a firstjaw having a proximal end and a distal end, the first jaw comprising afirst pivot between the proximal end and the distal end and a firstactuation post proximal the first pivot; and a second jaw having aproximal end and a distal end, the second jaw comprising a second pivotbetween the proximal end and the distal end and a second actuation postproximal the second pivot; and wherein the first pivot and the secondpivot pivotably couple the first jaw and the second jaw to the elongateshaft such that the first jaw and the second jaw are pivotable betweenan open configuration and a closed configuration; a jaw actuationmechanism at the distal end of the elongate shaft, the jaw actuationmechanism actuatable to pivot the first jaw and the second jaw betweenthe open configuration and the closed configuration; a suturing needlepositionable in the jaw assembly, the suturing needle comprising: aneedle having a generally curved profile and extending from a firstpenetrating tip to a second penetrating tip; and a suture coupled to theneedle.
 18. The laparoscopic suturing system of claim 17, wherein thejaw actuation mechanism comprises an actuator advanceable proximally anddistally relative to the elongate shaft.
 19. The laparoscopic suturingsystem of claim 18, wherein the actuator comprises actuation slotsformed therein and wherein the first actuation post and the secondactuation post are each positioned in an actuation slot such thatlongitudinal translation of the actuator pivots the first jaw and thesecond jaw between the open configuration and the closed configuration.20. The laparoscopic suturing system of claim 18, further comprising adrive rod slidable within the elongate shaft, the drive rod coupled tothe actuator to advance the actuator proximally and distally relative tothe elongate shaft.